Psychiatric disorders associated with PCSK9 inhibitors: A real-world, pharmacovigilance study.

ABSTRACT:

Background

The relationship between Protein Convertase Subtilisin Kexin Type 9 inhibitor (PCSK9i) and psychiatric adverse events (AEs) remains unclear due to the limitations of clinical trials. In this study, PCSK9i-related psychiatric AEs were realistically observed and systematically summarized in the real world by data mining the FDA AE Reporting System (FAERS).

Method

Total AEs between the third quarter of 2015 and the first quarter of 2023 were obtained from FAERS. Psychiatric AEs were identified using disproportionality analysis and clinical prioritization of signals using a rating scale, followed by univariate logistic regression to explore factors influencing psychiatric AEs.

Results

Psychiatric AEs accounted for 6.7% of the total number of PCSK9i reports. Eig

SUBMITTER: Deng Z 

PROVIDER: S-EPMC11017405 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature